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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Standard PVC Laryngeal Masks

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 Class 2 Device Recall Medline Standard PVC Laryngeal Maskssee related information
Date Initiated by FirmMarch 09, 2022
Create DateApril 14, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0941-2022
Recall Event ID 89821
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
ProductMedline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Code Information Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer Reason
for Recall		The mask cuff may disconnect from the device's breathing tube.
FDA Determined
Cause 2		Process control
ActionMedline Industries, Inc. notified all affected consignees via first class mail on March 8, 2022. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to be stored.
Quantity in Commerce8990 cases
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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